MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: BERMAN 4 FR 50CM; CATHETER, FLOW DIRECTED

Model Number	IPN000082
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the balloon bursts during usage on a patient.The 4-french catheter was inflated and deflated several times during the application (angiography); the customer described it as "permanent use"." it was reported that there was no harm or injury to the patient and the patient current condition is fine.
Event or Problem Description
It was reported that "the balloon bursts during usage on a patient.The 4-french catheter was inflated and deflated several times during the application (angiography); the customer described it as "permanent use"." it was reported that there was no harm or injury to the patient and the patient current condition is fine.
Additional Manufacturer Narrative
Qn#(b)(4).Teleflex received the device for investigation.The reported complaint that the "balloon bursts during usage" is not confirmed.The returned balloon passed functional testing and was fully intact.The returned device passed functional test specifications.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.No further action required at this time.

• Brand Name: CATH PKGD: BERMAN 4 FR 50CM
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; chelmsford MA
• MDR Report Key: 9813585
• Report Number: 2518433-2020-00003
• Device Sequence Number: 18985104
• Product Code: DYG
• UDI-Device Identifier: 00801902002266
• UDI-Public: 00801902002266
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: IPN000082
• Device Catalogue Number: AI-07134
• Device Lot Number: 16F19A0105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1